Pre-stressed pressure device

ABSTRACT

A pre-stressed pressure device for treating a wound or reducing scarring of a skin of a patient. the pre-stressed pressure device is composed of a pressure member having a curved state and a non-curved state, the pressure member having an inner surface and an outer surface. The pressure member has a central portion and first and second end portions, the central portion having a curved shape when the pressure member is in the curved state. The pre-stressed pressure device also contains a substrate assembly having a first surface side and a second surface side, the first surface side of the substrate assembly being secured to the inner surface of the pressure member and wherein the substrate assembly is no shorter than the pressure member. Further included is a treatment device connected to the second surface side of the substrate assembly, wherein the first and second end portions of the substrate assembly extend beyond a first and a second end of the treatment device; and an adhesive is located on the first and second end portions of the substrate assembly on the second surface side of the substrate assembly for applying the pre-stressed pressure device to the skin of the patient. The pressure member exerts end forces directed away from the patient and a central force directed towards the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a division of U.S. patent application Ser.No. 13/934,600, filed Jul. 3, 2013, entitled “PRE-STRESSED PRESSUREDEVICE”, which is currently pending.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates to a device and system for treating a patient.Specifically, the invention relates to a pre-stressed pressure devicethat applies pressure to a wound and/or scar to promote healing andreduce the appearance of scars and to a system for making and using thepre-stressed pressure device.

2. Description of the Related Art

Applying pressure to a patient's wound is beneficial because pressureprovides immediate hemostasis and decreases swelling and bruisingassociated with the wound. An added benefit for traumatic or surgicalwounds that require sutures is diminished swelling resulting in lesstension across the suture lines. This facilitates healing and improvesthe quality of the final scar by decreasing suture marks andirregularities formed in the skin as the tissue surrounding the woundheals.

Wounds may take many forms. Herein, “wound” is intended to be as broadlyinclusive as possible and means one or more injuries to at least theskin of a person. Wound may mean cuts and lacerations that areself-treated by a patient. It may also mean serious wounds caused bytraumatic injuries that are treated in a medical setting; wounds causedby surgery; or vascular cutaneous puncture sites such as intravenouscatheter, arterial catheter, or the like.

As wounds heal, applying pressure prevents scarring. The skin at anysite of the body comprises an intrinsic tension that stretches themarginal area of the skin surrounding the wound. The actual amount oftension may vary, depending upon the person, age, skin type, and woundlocation. Pre-existing skin conditions, such as scarring, may alsoaffect the intrinsic tension. During the intermediate phase of a woundhealing process (between 2 weeks and 12 weeks), the edges of a healingincision or wound, are pulled in different directions by surroundingskin, causing formation of the scar tissue.

Even after scarring has formed, applying pressure is an integralcomponent of a scar reduction regimen. Typically, a silicone gel sheetis fastened to a patient using a bandage wrapped tightly around thepatient's limb or torso. When combined with glucocorticoid steroids, theresult reduces the appearance of hypertrophic (thick) scars.

Herein, “scar” and/or “scarring” is intended to be as broadly inclusiveas possible and means at last one or more temporary or permanentdeformations of any part of the skin due to injury to the skin.

Unfortunately, to date, the various technologies available for providingpressure on a wound and/or scar require bulky or impractical devices.Thus, what is desired is a wound and scar treatment that providespressure to a wound and/or scar and that is compact and a system formaking and using that treatment.

SUMMARY OF THE INVENTION

These and other objectives are met by the present invention.

In accordance with one or more embodiments of the present invention, apre-stressed pressure device is preferably configured as a pressurebandage for treating a wound or to reduce scarring of the skin of apatient. The pressure bandage includes a substrate assembly having afirst surface, a pressure member having a curve in a central portion,the pressure member being secured to the substrate assembly; a treatmentdevice for exerting a pressure on the wound or the scarring, thetreatment device being connected to a first area of the first surface;and an adhesive for applying the pressure bandage to the skin, theadhesive being disposed on a second area of the first surface, the firstand second areas being non-overlapping.

In accordance with one or more embodiments of the present invention, apre-stressed pressure device is preferably configured as a pressurebandage for treating a patient. The pressure bandage includes asubstrate assembly, a treatment device mounted on the substrateassembly, an adhesive disposed on the substrate assembly, the adhesivefor securing the pressure bandage to the patient, and a pressure membersecured to the substrate assembly. Therein, the pressure member is in asubstantially curved state when the pressure bandage is not secured tothe patient.

The pressure member includes a center portion and an end portion, whichhave a different thickness or a different width from each other.

The pressure member includes a plurality of disconnected portionsdisposed in a plurality of planes.

A system for treating a wound or scarring of a patient includes apressure bandage comprising a pressure member having a pre-tension, a 3Dprinter for printing the pressure member, and a heater for selectiveheating an area of the pressure member to impart the pre-tension.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 a is a schematic plan view of a wound and scar being treated bythe present invention.

FIG. 1 b is a cross-sectional area view of the wound of FIG. 1 a beingtreated by the present invention and a pressure diagram associated withthe present invention.

FIG. 2 a is a top plan view of a pre-stressed pressure device that isconfigured as a bandage in accordance with one or more embodiments ofthe present invention.

FIG. 2 b is a bottom plan view of the bandage of FIG. 2 a.

FIG. 2 c is a longitudinal side view of the bandage of FIG. 2 b.

FIG. 2 d is a first transverse cross-sectional view of the bandage ofFIG. 2 a.

FIG. 2 e is a second transverse cross-sectional view of the bandage ofFIG. 2 a.

FIG. 2 f is a longitudinal cross-sectional view of the bandage of FIG. 2a.

FIG. 3 a is a schematic view of the bandage of the present invention ofFIG. 2 a prior to being applied to the wound of FIGS. 1 a and 1 b.

FIG. 3 b is a detail view of the treatment device of the presentinvention of FIG. 2 a after being applied to the wound of FIGS. 1 a and1 b.

FIG. 3 c is a schematic view of the present invention of FIG. 2 a afterbeing applied to the wound of FIGS. 1 a and 1 b and pressure diagramsassociated with the present invention.

FIG. 4 a is a longitudinal cross-sectional view of the pressure memberof the bandage of FIG. 2 a.

FIG. 4 b is a first transverse cross-sectional view of the pressuremember of FIG. 4 a.

FIG. 4 c is a second transverse cross-sectional view of the pressuremember of FIG. 4 a.

FIG. 5 a is a top plan view of a bandage in accordance with one or moreembodiments of the present invention.

FIG. 5 b is a bottom plan view of the bandage of FIG. 5 a.

FIG. 5 c is a longitudinal side view of the bandage of FIG. 5 b.

FIG. 6 a is a top plan view of a bandage in accordance with one or moreembodiments of the present invention.

FIG. 6 b is a bottom plan view of the bandage of FIG. 6 a.

FIG. 6 c is a longitudinal side view of the bandage of FIG. 6 b.

FIG. 7 a is a plan view of a pressure member in accordance with one ormore embodiments of the present invention.

FIG. 7 b is a cross-sectional view of the pressure member of FIG. 7 a.

FIG. 7 c is a first alternate cross-sectional view of the pressuremember of FIG. 7 a.

FIG. 7 d is a second alternate cross-sectional view of the pressuremember of FIG. 7 a.

FIG. 7 e is a plan view of a pressure member in accordance with one ormore embodiments of the present invention.

FIG. 7 f is a plan view of a pressure member in accordance with one ormore embodiments of the present invention.

FIG. 8 a is a plan view of a pressure member in accordance with one ormore embodiments of the present invention.

FIG. 8 b is a longitudinal cross-sectional view of the pressure memberof FIG. 8 a.

FIG. 8 c is an alternate longitudinal cross-sectional view of thepressure member of FIG. 8 a.

FIG. 9 a is a plan view of a pressure member in accordance with one ormore embodiments of the present invention.

FIG. 9 b is a plan view of a pressure member in accordance with one ormore embodiments of the present invention.

FIG. 9 c is a longitudinal cross-sectional view of the pressure memberof FIG. 9 b.

FIGS. 10 a-10 c and 11 a-11 c are, respectively, plan, side, and side onskin views of a bandage in accordance with one or more embodiments ofthe present invention.

FIG. 12 a is a longitudinal side view of a pre-stressed pressure devicethat is configured as a stress guard prior to being applied to a patientin accordance with one or more embodiments of the present invention.

FIG. 12 b is a longitudinal side view of the stress guard of FIG. 12 aapplied to a patient when initially applied to an open incision site.

FIG. 12 c is a longitudinal side view of the stress guard of FIG. 12 aafter being stressed.

FIG. 12 d is a first detail view of the stress guard of FIG. 12 a.

FIG. 12 e is a second detail view of the stress guard of FIG. 12 a.

FIG. 13 is a diagram illustrating a treatment system for making apre-stressed pressure device for treating a wound and/or reducingscarring in accordance with one or more embodiments of the presentinvention.

DETAILED DESCRIPTION OF THE INVENTION

The following detailed description is of the best mode or modes of theinvention presently contemplated. Such description is not intended to beunderstood in a limiting sense, but to be an example of the inventionpresented solely for illustration thereof, and by reference to which inconnection with the following description and the accompanying drawingsone skilled in the art may be advised of the advantages and constructionof the invention. In the various views of the drawings, like referencecharacters designate like or similar parts.

FIG. 1 a is a schematic plan of a wound and scar being treated by thepresent invention. FIG. 1 b is a cross-sectional area of the wound ofFIG. 1 a being treated by the present invention and a pressure diagramassociated with the present invention.

Therein, a patient 100 has sustained a wound 110 as is commonlyunderstood and at least as defined in the Description of the RelatedArt. The wound 110 has a wound area 112 that is determined by the typeand cause of the wound and a treatment area 114. The treatment areaextends from a regularized margin 116 of the wound to encompass thewound and an area most likely to be scarred by scarring 118, such ashypertrophic, as determined by a patient, but preferably by a qualifiedmedical practitioner. A “regularized margin” herein means a theoreticalmargin of the wound that extends in a regular geometric pattern of anellipse or a circle about the wound and touches the furthest extent ofthe actual margin of the wound at at least three points. To treat thewound 110 and prevent likely scarring 118, a pressure P, shown asexemplary pressure 190 in the pressure diagram of FIG. 1 b, is appliedby a treatment device (not shown) on at least the treatment area 114using a pressure bandage 10.

It should be understood that the present invention may also be appliedto only a scar. Therein, the wound area 112 is nil and the treatmentarea 114 extends to encompass the area scarred by scarring 118, such ashypertrophic scarring, as determined by a patient, but preferably by aqualified medical practitioner. To treat scarring 118, pressure P, isapplied by a treatment device on at least the treatment area 114 using apressure bandage 10.

Pressure P is preferably non-uniform and is greater over the treatmentarea 114 than in other areas where the pressure bandage is applied. Theparticular diagrammatic shape and/or amount of pressure P are dependenton the shape of a pressure member in plan view, thickness, and amount,i.e., degree of pre-stressing.

FIG. 2 a is a top plan view of a pre-stressed pressure device that isconfigured as a bandage in accordance with one or more embodiments ofthe present invention. FIG. 2 b is a bottom plan view of the bandage ofFIG. 2 a. FIG. 2 c is a longitudinal side view of the bandage of FIG. 2b. FIG. 2 d is a first transverse cross-sectional view of the bandage ofFIG. 2 a. FIG. 2 e is a second transverse cross-sectional view of thebandage of FIG. 2 a. FIG. 2 f is a longitudinal cross-sectional view ofthe bandage of FIG. 2 a.

FIG. 3 a is a schematic view of the bandage of the present invention ofFIG. 2 a prior to being applied to the wound of FIGS. 1 a and 1 b. FIG.3 b is a detail view of the treatment device of the present invention ofFIG. 2 a after being applied to the wound of FIGS. 1 a and 1 b. FIG. 3 cis a schematic view of the present invention of FIG. 2 a after beingapplied to the wound of FIGS. 1 a and 1 b and pressure diagramsassociated with the present invention.

FIG. 4 a is a longitudinal cross-sectional view of the pressure memberof the bandage of FIG. 2 a. FIG. 4 b is a first transversecross-sectional view of the pressure member of FIG. 4 a. FIG. 4 c is asecond transverse cross-sectional view of the pressure member of FIG. 4a.

In accordance with one or more embodiments of the present invention, apre-stressed pressure device is configured as a pressure bandage 10. Thepressure bandage 10 is preferably used for treating the wound 110 andcomprises a pressure member 14, a substrate assembly 16, and a treatmentdevice 22 joined to the substrate assembly. The pressure member 14 issecured to the substrate assembly 16 and applies a force to thetreatment device 22. In turn, the treatment device 22 applies pressureP, i.e., the pressure 190, within at least the treatment area 114 ofpatient 100 to promote healing and/or reduce scarring when the bandage10 is secured to the skin of the patient 100.

The pressure member 14 comprises one or more layers of one or morepressure materials.

A pressure material may be any suitable material that is elastic andcapable of holding an initial non-flat shape, preferably a curved shape.However, preferably, the pressure material is a polymer material. Morepreferably, the pressure material is selected from the group ofpolyvinyl chloride (PVC), acrylonitrile butadiene styrene (ABS); nylonpolymers including polyamide 6, polyamide 66, homopolymers, andco-polymers; polyester resin; low-density polyethylene terephthalate(PET); low-density polyethylene, high-density polystyrene; high-densitypolyethylene; and rubberized and/or plasticized PVC.

The pressure member 14 comprises, but not necessarily, a generallyrectangular shape in plan view having end portions 14 a (each defined asbeing generally, but not necessarily, the one-third end area in planview of the pressure member) spaced distal from a central portion 14 b(defined as being generally, but not necessarily, the center one thirdarea in plan view of the pressure member) and has a thickness 14 c. Thethickness 14 c is preferably sufficient to prevent the longitudinaledges of the pressure member 14 from curling inwards towards thelongitudinal centerline of the pressure member. That is, the thickness14 c is chosen such that the pressure member remains rigid in across-section perpendicular to the longitudinal centerline of thepressure member.

Therein, the thickness 14 c may be varied as needed for the specificembodiment of the bandage 10 and may be non-uniform and variable inthickness across the width and/or along the length of the pressuremember 14. The thickness preferably also provides the bandage 10 withsufficient load carrying capacity to achieve the desired pressurestrains needed for the therapeutic effect on the wound 110 and/or thescarring 118. The thickness 14 c of the pressure member 14 may betapered near the edges for added comfort and/or safety of use.

The pressure member 14 normally has a curved shape in at least part ofthe central portion 14 b while the end portions 14 a are straight. Inother words, the pressure member 14 has a normally curved state 15 a,i.e., first state. This state occurs prior to the pressure bandage 10being applied to the skin of the user.

The curved shape in at least part of the central portion 14 b may beachieved by casting, extruding, and/or forming central portion to becurved. Therein, the central portion 14 b may have any suitable curvewhile the end portions 14 a are straight.

The curved shape may also be made by pre-stressing the pressure memberin a pre-stressed area 14 d (FIG. 4 a), such as being heat-treated.Therein, the pre-stressed area 14 d is preferably disposed in thecentral portion 14 b. In the pre-stressed area, the pressure member hasbeen stressed increasing the compression side 14 e, moving the neutralaxis 14 f in the pre-stressed area 14 d, and causing the tension side 14g to be reduced.

In the curved state 15 a, the pressure member 14 is curved in thepre-stressed area 14 d, i.e., at least part or all of the centralportion 14 b, while the end portions 14 a are straight. Therein, the endportions 14 a are preferably, but not necessarily, equidistant from thecentral portion 14 b in lateral and offset directions and are curved inthe same direction. When the pressure member 14 is in the curved state15 a, the bandage 10 generally follows the same curved contour as thepressure member 14 and also is in the curved state 15 a.

When the bandage 10 has been applied to the patient 100, the pressuremember 14 will be in a non-curved, substantially non-curved state 15 b,i.e., second state. When the pressure member 14 is in substantially thenon-curved state 15 b, the bandage 10 generally follows the same contouras the pressure member 14 and also is in substantially the non-curvedstate 15 b. The non-curved state 15 b may be a flat state or contour,and/or may be one where the pressure member, i.e., pressure bandage,follows the contour of the skin.

In the substantially non-curved state 15 b, the pressure member 14exerts a force F1. The force F1 has end forces F1 a and F1 b directedaway from the patient 100 and a central force F1 c directed toward thepatient 100 and forcing the treatment device 22 onto at least thetreatment area 114. That is, when the pressure member 14 isstraightened, the region of the pressure member 14 that has not beenpre-stressed will pull upwards with forces F1 a and F1 b in an evenlydispersed manner while the force F1 c in the region that has beenpre-stressed, i.e., the central portion 14 b, will be applied downwardwith a force equal to the sum of the forces F1 a and F1 b. The force F1c will be at maximum at the center the pressure member vary along thecentral portion 14 b.

Advantageously, the pressure material may be pre-stressed to apredetermined amount, and thus, the amount of curvature may beselectively predetermined to the pressure member 14. In turn, by varyingthe curvature, the central portion 14 b can be predetermined to exert aspecific force F1 c on the wound 110. In addition or in the alternative,the shape and/or the thickness 14 c of the pressure member may beselected, as taught further herein, to provide further predeterminedrefinement of the force F1 c. For example, by increasing the size of theedge portions 14 a relative to the central portion 14 b, a greater forceF1 c will be generated. The force F1 c is transferred as pressure to thepatient via the treatment device, since pressure is force per unit area.

Therein, increasing the force F1 c will yield an increase in pressureapplied to at least the treatment area 114 via the treatment device.

The pressure member 14 may have a thickness of 100 microns to at least 1mm, but preferably with a range of about 220 microns to about 500microns, or more preferably 300 microns to 400 microns.

The substrate assembly 16 comprises at least two substrate members 18 a,18 b and an adhesive 20 a applied in an adhesive area 20 b of thesubstrate assembly 16. Substrate members 18 a, 18 b may be made of anysuitable material 19 a that is durable, stretchable, and resilientlyflexible as is known in the art for adhesive bandages.

However, preferably, each substrate member, when made of a single layer,comprises or consists of a material 19 a and, when made of a multilayerstructure, comprises a covering made of a material 19 a and one or moresupport layers made of a material 19 b. The material 19 a used may bemade entirely of or comprise a woven material such as cloth in anysuitable weave strength and may metal-detectable fabric, such as metalfibers, to permit the use of the bandage 10 in food service and/orprocessing industry. The material 19 a may also be a light wovenmaterial for comfort or a heavy woven material for protection. Thematerial may be chosen such that it is air permeable to permit air toaccess the wound 110 and/or the treatment area 114.

The material 19 a may also be made entirely of or comprise a plasticmaterial or rubber material as is known in the art for adhesive bandagesdue to their excellent stretchability, costs, and/or wearability.

The substrate members 18 a and 18 b may also comprise a multilayerstructure. Therein, one or more material layers comprise or consist of amaterial 19 b, which may be cotton, artificial and/or natural fibers,artificial and/or natural gel materials, natural or artificial foamedrubber and/or vinyl, or a combination thereof may be added to thecovering.

The adhesive 20 a may be one or more suitable pressure-sensitiveadhesives as is known in the art for adhesive bandages. Due to theirexcellent adhesion strength, usability, costs, and/or length of use, theadhesive 20 a is preferably selected from the group of acrylic,silicone, butyl rubber, nitrile, styrene block copolymers (SBC),ethylene-vinyl acetate (EVA), or a combination thereof. In addition orin the alternative, the adhesive 20 a may be a polyacrylate-based,polyisobutylene-based, and/or silicone-based pressure-sensitiveadhesive; or a synthetic rubber, acrylic, hydrocolloid, or a likecompound adhesive. In addition or in the alternative, the adhesive 20 amay also be a light-curable or heat-curable adhesive.

Preferably, regardless of type, the adhesive 20 a comprises a T-peelrelease force of in the range of 0.45 N/cm to at least 19 N/cm. Therein,the T-peel release force and blunt probe tack force ofpressure-sensitive adhesives is in accordance with ASTM D1876 and ASTMD2979 or other appropriate methods.

The adhesive 20 a is applied in the adhesive area 20 b to the substrateassembly. Therein, the adhesive area 20 b is preferably a marginal areaof the substrate assembly 16 that surrounds the treatment device 22 andis non-overlapping with the treatment device 22, which is also attachedto the substrate assembly 16, to provide maximum adhesion to the skin ofthe patient 100.

The substrate members 18 a and 18 b are preferably sized similarly anddefine the maximum extent of both the bandage 10 and the substrateassembly 16 in plan view. In accordance with one or more embodiments ofthe present invention, a pressure bandage 10 exerts a pressure P havinga pressure component 190 and one or more pressure components 191. Thepressure component 190 is the result of the force F1 and F2 and eachpressure component 191 is the result of only the force F2.

The minimum size of the substrate assembly 16 is determined by the sizeof the adhesive area 20 b needed for an adhesive 20 a to create theforce F2 to overcome the forces F1 a and F1 b of the pressure member andto adhere the bandage 10 to the skin with sufficient forces to overcomeunintended removal of the bandage 10 from the skin. Thus, when thebandage 10 has been applied to the patient 100, at least the force F1 cis exerted onto the treatment device 22, in turn, creating the pressure190 onto at least the treatment area 114.

In accordance with one or more other embodiments of the presentinvention, the size of the substrate assembly 16 may be determined bythe size of adhesive area 20 b needed for the adhesive 20 a to createthe force F2 to overcome at least the forces F1 a and F1 b of thepressure member, to adhere the bandage 10 the skin of the patient withsufficient forces to overcome unintended removal of the bandage 10 fromthe skin, and, further to add to the pressure applied by the pressuremember 14 to the treatment device. Thus, preferably, the adhesive placedin the adhesive area 20 b exerts a force F2 onto the substrate assembly16, or more specifically, to the pressure member 14 to prevent thepressure member from removing the bandage from the skin of the patient.Thus, when the bandage 10 has been applied to the patient 100, the forceF1 c and a portion of the force F2 is exerted onto the treatment device22, in turn, creating the pressure 190 onto at least the treatment area114.

The pressure member 14 may be disposed in the substrate assembly 16 bybeing embedded or sandwiched between the substrate members 18 a and 18 band additionally may be secured as described below. However, thepressure member 14 may also be disposed or embedded solely within one ofthe substrate members or may be embedded such that alongitudinally-extending or laterally-extending portion of the pressuremember is embedded solely in one substrate member. The otherlongitudinally-extending or laterally-extending portion of the pressuremember is then embedded in the other substrate member or when three ormore substrate members are present in one or more of the other substratemembers.

In addition, the pressure member 14 may be joined to, joined with,disposed in, or disposed on, or embedded in the substrate using anadhesive, sonic welding, heating, stamping, or any other suitable meansthat aids in avoiding unintended movement of the pressure member 14relative to the substrate assembly 16.

Regardless of how the pressure member 14 is disposed in the substrateassembly 16, the substrate assembly 16 comprises a marginal edge area 18c in plan view between a perimeter of the pressure member and aperimeter of the substrate assembly. The marginal edge area 18 c alsoadvantageously aids in keeping the pressure member 14 securely locatedrelative to the substrate assembly 16.

The substrate members 18 a and 18 b may be secured to each other byusing an adhesive, sonic welding, heating, stamping, or any othersuitable means that aids in avoiding unintended movement of thesubstrate members relative to each other. Moreover, the perimeter and/ora perimeter margin of the substrate assembly 16 may have a finished andreduced thickness relative to other portions of the substrate assembly16 by crimping, flattening, sonically welding, and/or stamping theperimeters of the substrate members 18 a, 18 b. This advantageouslyprevents the unintended separation of the substrate members from eachother.

The treatment device 22 is joined to the substrate assembly 16 using anadhesive, sonic welding, heating, stamping, or any other suitable meansthat aids in avoiding unintended dislocation of the treatment devicerelative to the substrate assembly.

In accordance with one embodiment of the present invention, thetreatment device 22 may comprise or consist of an absorbent pad madefrom cotton gauze or fabric, but the treatment device 22 may alsocomprise or consist of an absorbent material impregnated with one ormore anti-bacterial agents or substances generally known in the art.

The treatment device 22 may also may comprise or consist of one or morescar reducing materials such as silicone formed into a pad.

The treatment device 22 may also comprise or consist of a combinationpad wherein a skin proximal layer is an absorbent material joined to askin distal layer made of one or more scar reducing materials. Thisadvantageously immediately permits hemostasis and initiates a regimen ofscar reduction.

In accordance with one or more embodiments of the present invention, thetreatment device 22 for a wound may comprise an absorbent material andmay have a thickness of approximately 220-500 microns at a center of thepad for maximum comfort and absorbency while marinating a clinicallysuitable pressure on the wound. The treatment device 22 may have asilicone pad for scar reduction and may achieve a pressure of 10 to 25mm Hg, i.e., 10 to 25 Torr, of pressure under the pad for a clinicallysuitable pressure to reduce scarring.

In accordance with one or more embodiments of the present invention, thetreatment device 22 may comprise one or more therapeutic agentsbeneficial to wound healing and/or scar reduction that may be disposedin or on the absorbent pad of the treatment device, but also packagedwith bandage 10 in a kit. For example, therapeutic agents may be VitaminE and/or one or more hemostatic and/or coagulative agents. Hemostaticand/or coagulative agents may comprise epinephrine, calcium alginate,calcium-loaded zeolite, cellulose, microfibrillar collagen, fibrinogen,glucosamine, thrombin, coagulation factors (e.g. II, VI, VII, X, XIII,VWF), procoagulants, antifibrinolytics (e.g. epsilon aminocaproic acid),and/or similar compounds.

A therapeutic agent may also be an antibiotic disposed in or on thetreatment device, but also packaged with the bandage 10 in a kit. Atherapeutic agent may be, but is not limited to, cephalosporins,polymyxin B sulfate, bacitracin, neomycin, polysporin), antiseptics(such as iodine solutions, silver sulfadiazine, chlorhexidine) and/orother treatments (e.g. botulism toxin, growth factors).

The bandage 10 preferably includes a pair of protective sheets disposedon the side proximal to the treatment device as are generally known inthe art.

The bandage 10 may also be packaged in a sterile packaging that iseasily removable by peeling two protecting sheets apart as is generallyknown in the art.

Since the bandage 10 generally follows the same curved contour as thepressure member 14 in the curved state 15 a, the curved shape of thebandage, advantageously, permits nested packaging.

A plurality of the bandages 10 may be packaged to have treatment regimenstarting with control of the wound using the bandages having treatmentdevices consisting of absorbent pads to bandages having treatmentdevices consisting of combination pads and ending with bandages havingtreatment devices having only scar reducing materials.

In accordance with one or more embodiments of the present invention, thebandage 10 may also be used for treatment of skin-related conditionssuch as skin injuries, including for example, incisions, acute orchronic wounds, ulcers, and venopuncture areas; preventing or reducingthe incidence of wound infections, swelling and hematoma formation;treatment of skin irritation and sensitivity, skin paresthesia,allodynia, dermatitis, warts, rashes, acne, and psoriasis; management ofarteriovenous malformations; treatment or improvement of wrinkles,scars, stretch marks or other skin irregularities; and/or delivering adrug to the skin or through the skin.

In accordance with one or more embodiments of the present invention, thebandage 10 further comprises, in any convenient location, one or moredesigns, logos, advertisements, treatment information, contact names andnumbers, and/or marketing information.

In accordance with one or more embodiments of the present invention, thebandage 10, as for example, illustrated in FIGS. 2 a-2 f and 3 a-3 c,comprises a length 11 a of approximately 50 mm to 190 mm and a width 11b of 22 mm to 100 mm. The bandage further comprises a thickness 11 c inthe range of 100 microns to at least 1 mm. Greater thicknesses may bepossible depending on the thickness of the pressure member and generallyvary between 1 mm to 3 mm.

Other bandages 10 may be suitably dimensioned in accordance with needsassociated with a wound 110 or scarring 118.

FIG. 5 a is a top plan view of a bandage in accordance with one or moreembodiments of the present invention. FIG. 5 b is a bottom plan view ofthe bandage of FIG. 5 a. FIG. 5 c is a longitudinal side view of thebandage of FIG. 5 b.

In accordance with one or more embodiments of the present invention, abandage 10 a is constructed similarly to bandage 10 except that thesubstrate assembly 16 has been replaced with a substrate assembly 16 a,which comprises a single substrate member 18 a. The single substratemember, preferably, comprises one or more layers made of material 19 band at least one covering made of material 19 a. However, preferably,two coverings made of material 19 a sandwich the one or more layer madeof material 19 b. Therein, the pressure member 14 may be disposed withinthe single substrate member in a manner taught above.

The substrate member 18 a may also consist of a single structural layermade of material 19 a. Then, the pressure member 14 is joined to anunderside of the substrate member 18 a, i.e., the substrate assembly 16,using an adhesive, sonic welding, heating, stamping, or any othersuitable means that aids in avoiding unintended removal of the pressuremember.

The treatment device 22 is then secured directly to the pressure memberby an adhesive, sonic welding, heating, stamping, or any other suitablemeans that aids in avoiding unintended movement of the treatment devicerelative to pressure member.

Thus, the adhesive area 20 b is disposed directly on the underside ofthe substrate member 18 a and may also be disposed at least partially onan area of the pressure member 14 that is not covered by the treatmentdevice 22.

Advantageously, the bandage 10 a provides a simple and cost effectiveconstruction.

FIG. 6 a is a top plan view of a bandage in accordance with one or moreembodiments of the present invention. FIG. 6 b is a bottom plan view ofthe bandage of FIG. 6 a. FIG. 6 c is a longitudinal side view of thebandage of FIG. 6 b.

In accordance with one or more embodiments of the present invention, abandage 10 b is constructed similarly to bandage 10 except that thepressure member 14 is secured to the substrate assembly 16 on a sideopposite to a side to which the treatment device 22 are secured.

Therein, the pressure member 14 is secured to a first side 16 b of thesubstrate assembly 16. The substrate assembly 16 may be any substrateassembly as taught above, but, preferably, the substrate assembly 16comprises a single substrate member 18 a that, in turn, consists of asingle structural layer made of material 19 a. The pressure member issecured to the first side by an adhesive, sonic welding, heating,stamping, or any other suitable means that aids in avoiding unintendedmovement of the pressure member relative to the substrate assembly.

The treatment device 22 is secured directly to a second side 16 c of thesubstrate assembly 16 by an adhesive, sonic welding, heating, stamping,or any other suitable means that aids in avoiding unintended movement ofthe treatment device relative to pressure member.

The adhesive area 20 b is disposed directly on the underside of thesubstrate member 18 a, i.e., substrate assembly 16, in an area notcovered by the treatment device 22.

FIG. 7 a is a plan view of a pressure member in accordance with one ormore embodiments of the present invention. FIG. 7 b is a cross-sectionalview of the pressure member of FIG. 7 a. FIG. 7 c is a first alternatecross-sectional view of the pressure member of FIG. 7 a. FIG. 7 d is asecond alternate cross-sectional view of the pressure member of FIG. 7a.

Therein, a pressure member 202 is substantially identical to thepressure member 14 and may be used in any of the bandages taught above.However, the pressure member 202 comprises end portions 202 a, whichcorrespond to end portions 14 a, that are wider laterally than centralportion 202 b, which corresponds to the central portion 14 b.Advantageously, the configuration permits increasing the forces F1 a andF1 b and placing the force F1 c over a smaller surface area. Sincepressure is the force per unit area, the force F1 c will thus be able toincrease pressure the treatment device by concentrating the pressureover a smaller area.

In addition or in the alternative, the pressure member 202 comprisesridges 202 c that may be squared, rounded, or peaked and aid inincreasing the amount of pre-tensioning possible and increasing theforce F1 c.

FIG. 7 e is a plan view of a pressure member in accordance with one ormore embodiments of the present invention. Therein, a pressure member204 is substantially identical to pressure member 14 and may be used inany of the bandages taught above. However, pressure member 204 comprisesend portions 204 a, which correspond to end portions 14 a, that arewider laterally than the central portion 204 b, which corresponds tocentral portion 14 b. End portions 204 a include one or moreindentations 204 c, which permits the pressure member 204 to be moreflexible at the end portions and be fitted in unusual anatomicalsituations to a patient.

FIG. 7 f is a plan view of a pressure member in accordance with one ormore embodiments of the present invention. Therein, a pressure member206 is substantially identical to pressure member 14 and may be used inany of the bandages taught above. However, the pressure member 206comprises end portions 206 a and central portions 206 b, all of whichhave been widened, but have portions that connect them and that are notas wide as the portions 206 a and 206 b.

FIG. 8 a is a plan view of a pressure member in accordance with one ormore embodiments of the present invention. FIG. 8 b is a longitudinalcross-sectional view of the pressure member of FIG. 8 a. FIG. 8 c is analternate longitudinal cross-sectional view of the pressure member ofFIG. 8 a.

Therein, a pressure member 208 is substantially identical to pressuremember 14 and may be used in any of the bandages taught above. However,the pressure member 208 comprises end portions 208 a, which correspondto end portions 14 a, that are wider laterally than central portion 208b, which corresponds to central portion 14 b. End members 208 a may alsohave a greater thickness than central portion 208 b. The difference inthickness may be distributed relative to one or both sides of thecentral portion. Advantageously, the configuration permits increasingforces F1 a and F1 b and placing force F1 c over a smaller surface area.Since pressure is the force per unit area, force F1 c will thus be ableto increase pressure the treatment device by concentrating the pressureover a smaller area.

FIG. 9 a is a plan view of a pressure member in accordance with one ormore embodiments of the present invention. FIG. 9 b is a plan view of apressure member in accordance with one or more embodiments of thepresent invention. FIG. 9 c is a longitudinal cross-sectional view ofthe pressure member of FIG. 9 b.

Therein, a pressure member 210 is substantially identical to pressuremember 14 and may be used in any of the bandages taught above. However,the pressure member 210 comprises a plurality of disconnected strips 210a that may be arranged in one or more planes. This permits the pressuremember to be more flexible.

The pressure member 210 may also comprise a plurality of disconnectedstrips 210 a and 210 b that may be arranged in one or more planes and/ormay be stacked on top of each other.

The strips 210 b are preferably, but not necessarily, arranged at theend portions of the pressure member 210 causing the pressure member tohave a greater thickness at one or more end portions than a centralportion. This permits the pressure member to be more flexible as well asincreasing the forces F1 a and F1 b and placing the force F1 c over asmaller surface area. Since pressure is the force per unit area, theforce F1 c will thus be able to increase pressure on the treatmentdevice.

FIGS. 10 a-10 c and 11 a-11 c are, respectively, plan, side, and side onskin views of a bandage in accordance with one or more embodiments ofthe present invention. Therein, a bandage 10 d or 10 e comprises aplurality of pressure members 14 that are arranged to overlap and/orhave a woven configuration. This permits the bandages 10 d and 10 e toconform in not flat situations, such as the antecubital fossa.

FIG. 12 a is a longitudinal side view of a pre-stressed pressure deviceis configured as a stress guard prior to being applied to a patient inaccordance with one or more embodiments of the present invention. FIG.12 b is a longitudinal side view of the stress guard of FIG. 12 aapplied to a patient when initially applied to an open incision site.FIG. 12 c is a longitudinal side view of the stress guard of FIG. 12 aafter being stressed. FIG. 12 d is a first detail view of the stressguard of FIG. 12 a. FIG. 12 e is a second detail of the stress guard ofFIG. 12 a.

A pre-stressed pressure device is configured as a stress guard 40.Returning to FIG. 1 a, the stress guard 40 is preferably used to treatthe wound 110, which may be a wound caused by a surgical incision, andprevent scarring associated with the wound. Therein, the wound 110typically will be sutured, and, thus, the wound area 112 is nil and thetreatment area 114 extends to encompass the area scarred by scarring118. To treat the wound 110 and prevent likely scarring 118, a pressure192, i.e., a stress 192 is applied by a treatment device on at least aportion of the treatment area 114 using the stress guard 40.

Therein, the stress guard 40 is preferably pre-stressed with a curvedesigned to maximize inward force while applied to the skin withpreferably a peelable adhesive disposed on end portions of the stressguard but not on the central portion. The stress guard can be manuallystrained and applied flat to the skin. The stress at the wound site maybe reduced to the levels below that experienced by normal skin.

In accordance with one or more embodiments of the present invention, thestress guard 40 comprises a pressure member 44, which exerts pressure192 on the wound 110 to close the wound area 112, if open, and/orrelieve stress in the wound area 112, and an adhesive 46 a applied inone or more adhesive areas 46 b.

The pressure member 44 comprises one or more layers of one or morepressure materials. A pressure material may be any suitable materialthat is elastic and capable of holding an initial non-flat shape,preferably a curved shape. However, preferably, the pressure material isa polymer material. More preferably, the pressure material is selectedfrom the group of polyvinyl chloride (PVC), acrylonitrile butadienestyrene (ABS); nylon polymers including polyamide 6, polyamide 66,homopolymers, and co-polymers; polyester resin; low-density polyethyleneterephthalate (PET); low-density polyethylene, high-density polystyrene;high-density polyethylene; and rubberized and/or plasticized PVC.

The pressure member 44 comprises, but not necessarily, a generallyrectangular shape in plan view having end portions 44 a (each defined asbeing generally, but not necessarily, the one-third end area in sideview of the pressure member) spaced distal from a central portion 44 b(defined as being generally, but not necessarily, the center one thirdarea in side view of the pressure member) and has a thickness 44 c. Thethickness 44 c is preferably sufficient to prevent the longitudinaledges of the pressure member 44 from curling inwards towards alongitudinal centerline of the pressure member. That is, the thickness44 c is chosen such that the pressure member remains rigid in across-section perpendicular to the longitudinal centerline of thepressure member.

Therein, the thickness 44 c may be varied as needed for the specificembodiment of the stress guard 40 and may be non-uniform and variable inthickness across the width and/or along the length of the pressuremember 44. The thickness preferably also provides stress guard withsufficient load carrying capacity to achieve the desired pressure 192.The thickness 44 c of the pressure member 44 may be tapered near theedges for added comfort and/or safety of use.

The pressure member 44 normally has a curved shape in at least part ofthe central portion 44 b while the end portions 44 a are straight. Inother words, the pressure member 44 has a normally curved state 45 a,i.e., first state. This state occurs prior to the stress guard 40 beingapplied to the skin of the user.

The curved shape in at least part of the central portion 44 b may beachieved by casting, extruding, and/or forming central portion to becurved. Therein, the central portion 44 b may have any suitable curvewhile the end portions 44 a are straight.

The curved shape may also be made by pre-tensioning the pressure memberin a pre-stressed area (not shown), such as being heat-treating.Therein, the pre-stressed area is preferably disposed in the centralportion 14 b. In the pre-stressed area, the pressure member has beenstressed increasing a compression side, moving the neutral axis in thepre-stressed area, and causing a tension side to be reduced.

In the curved state 45 a, the pressure member 44 is curved in thepre-stressed area, while the end portions 44 a are straight. Therein,the end portions 44 a are preferably, but not necessarily, equidistantfrom the central portion 44 b in lateral and offset directions and arecurved in the same direction. When the pressure member 44 is in thecurved state 45 a, the stress guard 40 generally follows the same curvedcontour as the pressure member 44 and also is in the curved state 45 a.

In accordance with one or more embodiments of the present invention, oneor more hinges 43 define the boundary between the central portion 44 band respective end portions 44 a. Therein, the hinge 43 may be a plastichinge or hinge having a groove or a channel 43 a. The groove or channel43 a may be formed to be a V opening wherein each leg of the V has equallength, or has an unequal length.

Preferably, the adhesive 46 a may be one or more suitablepressure-sensitive adhesives as is known in the art for adhesivebandages. Due to their excellent adhesion strength, usability, costs,and/or length of use, the adhesive 46 a is preferably selected from thegroup of acrylic, silicone, butyl rubber, nitrile, styrene blockcopolymers (SBC), ethylene-vinyl acetate (EVA), or a combinationthereof. In addition or in the alternative, the adhesive 46 a may be apolyacrylate-based, polyisobutylene-based, and/or silicone-basedpressure-sensitive adhesive; or a synthetic rubber, acrylic,hydrocolloid, or a like compound adhesive. In addition or in thealternative, adhesive 46 a may also be a light-curable or heat-curableadhesive.

Preferably, regardless of type, adhesive 46 a comprises a T-peel releaseforce of in the range of 0.45 N/cm to at least 19 N/cm. Therein, theT-peel release force and blunt probe tack force of pressure-sensitiveadhesives is in accordance with ASTM D1876 and ASTM D2979 or otherappropriate methods.

The adhesive 46 a is applied in the adhesive area 46 b, which ispreferably a portion of or all of end portions 44 a. The adhesive 46 ais preferably not applied in the central portion 44 b.

The stress guard 40 is applied to the patient 100, for example, bystraining it manually and then using the adhesive 46 a to secure it toskin of the patient. Therein, the pressure member 44 will be in anon-curved, substantially the non-curved state 45 b, i.e., second state.When the pressure member 44 is in substantially non-curved state 45 b,the stress guard 40 follows the same contour as the pressure member 44and also is in substantially the non-curved state 45 b. Substantiallynon-curved state 45 b may be a flat state or contour, and/or may be onewhere the pressure member, i.e., stress guard, follows the contour ofthe skin.

In either curved state 45 a or substantially the non-curved state 45 b,the pressure member 44 has the forces F3 and F4, which combine aspressure 192 and are directed toward each other to pull the wound 110closed. That is, when the pressure member 44 is curved, the forces F3and F4 pull toward each other closing the wound 110 or keeping themarginal edges of the wound closed.

Preferably, a stress guard 40 is selected so that it is sufficientlysized, for example, by laying in a substantially non-curved state 45 bwhen applied to a wound, as shown in FIG. 12 b, and the wound's edgesare being pulled toward each other to close the wound area 112, if open,and/or relieve stress in the wound area 112. As the wound heals, thewound area 112 becomes nil and the stress guard changes to asubstantially curved state 45 a.

Advantageously, the pressure material may be pre-stressed to apredetermined amount, and thus, the amount of curvature may beselectively predetermined to the pressure member 44. In turn, by varyingthe curvature, the central portion 44 b can be predetermined to exertspecific forces F3 and F4 on the wound 110. In addition or in thealternative, the shape and/or the thickness 44 c of the pressure membermay be selected, as taught further herein, to provide furtherpredetermined refinement of forces F3 and F4. Forces F3 and F4 aretransferred as pressures to the patient via the treatment device, sincepressure is force per unit area.

Therein, increasing forces F3 and F4 will yield an increase in pressureapplied to at least the treatment area 114 via the treatment device.

The pressure member 44 may have a thickness of 100 microns to at least 2mm, but preferably with a range of about 220 microns to about 500microns, or more preferably 300 microns to 400 microns. The pressuremember 44 preferably has a length of approximately 10 mm to 190 mm,i.e., 1 cm to 19 cm, and/or a width of 8 mm to 100 mm, i.e., 0.8 cm to10 cm.

In accordance with one or more embodiments of the present invention, akit for treating the wound 110 of the patient 100 comprises twodifferent types pre-stressed pressure devices, i.e., the pressurebandage 10 and the stress guard 40, used at different times during thetreatment for effective wound healing and to reduce the possibility ofscarring. The pressure bandage 10 is indicated for use during the acuteand late wound phases. These phases are immediately after the occurrenceof the wound and up to 2 weeks after the occurrence of the wound. Totreat the wound during the intermediate phase, between 2 and 12 weeks,the stress guard 40 is indicated. Therein, the system offers an ultimatesolution to the skin wound treatment and scar tissue relief.

FIG. 13 is a diagram illustrating a treatment system for making apre-stressed pressure device for treating a wound and/or reducingscarring in accordance with one or more embodiments of the presentinvention. Therein, the treatment system 500 for treating a wound and/orreducing scarring comprises an imaging device 502, a computing device504 executing a computer-readable software 506 stored on anon-transitory computer readable media 508, a 3D printer 510, a supply512 of pressure material, a heating device 514, a supply 516 ofsubstrate members 18 a and 18 b, and a supply 518 of treatment device22.

Therein, when a patient 100 presents with a wound 110 or with scarring,a user of the system, who preferably, but not necessarily a qualifiedmedical professional, uses imaging device 502, such as a digital camera,smartphone camera, ultraviolet imaging apparatus, to take an image ofthe wound or scarring and/or the contours of the area surrounding thewound or scarring. Using a network or a storage device, the image isthen transferred to a computing device 504 such as a computer, mainframedevice, tablet computer, smartphone, or other device. The network hereinmay be any kind of network including a cellular, wireless, Wi-Fi, LAN,Ethernet, internet, private, public, or a combination thereof.

In accordance with one or more embodiments of the present invention, theimage is utilized by the user to define treatment area 114. Software 506stored on a non-transitory computer readable media 508, such as CD-ROMor DVD, uses the defined treatment and/or contours of the surroundingarea to design the pressure member 14, including the shape of the endportions 14 a, the central portion 14 b, the thickness 14 c for anyportion and any variations therein as taught above, and transmits thatinformation, preferably over a network, to the 3D printer 510. Thesoftware then also calculates the amount of pre-tensioning required andtransmits that information, preferably over a network, to heating device514.

Therein, the 3D printer 510 may be any suitable additive manufacturingprinter. The printer 510, using supply 512 of the pressure material,manufactures the pressure member 14 according to the information sent bycomputing device. The same user or another user then places the pressuremember in the heating device 514.

The heating device 514 may be any kind of suitable device that impartsenergy into the pressure member 14. Thus, heating device 514 may be amicrowave, a radiant heater, a sonic welding device, or a combinationthereof. Using the information sent by the computing device, the heatingdevice 514 heats the pressure device 14 in the pre-stressed area 14 d toimpart the pre-tensioning. In order to prevent unintended heating, aprotective layer may be printed on areas of the pressure device otherthan the pre-stressed area 14 d.

In addition or in the alternative, the pressure member 14 may also bemade to be curved in the printer 512 and heating with the heating device514 may not be necessary.

After the pre-tensioning has been imparted in the pressure member 14, itis joined to one or more substrate members 18 a and 18 b that areprovided via a supply 516 and a treatment device 22 from the supply 518.If necessary, the substrate members 18 a and 18 b and the treatmentdevice 22 may be sized according to sizing information provided by thecomputing device 504 to produce a pre-stressed pressure deviceconfigured, for example, as the bandage 10 that may be applied to thepatient. Similarly, the stress guard 40 may be produced by the treatmentsystem 500 by itself and/or in conjunction with the pressure bandage 10.

While the invention has been described in conjunction with specificembodiments, it is to be understood that many alternatives,modifications, and variations will be apparent to those skilled in theart in light of the foregoing description.

1. A pressure bandage for treating a patient, the pressure bandagecomprising: a substrate assembly having a first surface side and asecond surface side, as well as first and second end portions; apressure member having a curved state and a non-curved state, thepressure member having an inner surface and an outer surface, thepressure member also comprising a central portion and first and secondend portions, the central portion having a curved shape when thepressure member is in the curved state and the pressure member beingconnected to the second side of the substrate assembly; a treatmentdevice mounted on a center portion of an underside of the substrateassembly between the first and second end portions of the substrateassembly, wherein the first and second end portions of the substrateassembly extend beyond first and second ends of the treatment device; anadhesive disposed on the first and second end portions of the substrateassembly, the adhesive for securing the substrate assembly and thepressure member to the patient, wherein the pressure member exerts endforces directed away from the patient and a central force directedtowards the patient.
 2. The pressure bandage of claim 1, wherein thecenter portion and the first and second end portions of the pressurebandage have a different thickness or a different width from oneanother.
 3. The pressure bandage of claim 1, wherein the treatmentdevice comprises an absorbent pad, a silicone pad, a gauze, ananti-bacterial agent treated pad, a coagulant agent treated pad, ahemostatic agent treated pad, a vitamin E treated pad, an antibiotictreated pad, an antiseptic treated pad, a botulism toxin treated pad, ora growth factors treated pad.
 4. A pre-stressed pressure device fortreating a wound or reducing scarring of a skin of a patient, thepre-stressed pressure device comprising: a pressure member having acurved state and a non-curved state, the pressure member having an innersurface and an outer surface, the pressure member also comprising acentral portion and first and second end portions, the central portionhaving a curved shape when the pressure member is in the curved state; asubstrate assembly having a first surface side and a second surfaceside, the first surface side of the substrate assembly being secured tothe inner surface of the pressure member and wherein the substrateassembly is no shorter than the pressure member; a treatment deviceconnected to the second surface side of the substrate assembly, whereinthe first and second end portions of the substrate assembly extendbeyond a first and a second end of the treatment device; and an adhesivelocated on the first and second end portions of the substrate assemblyon the second surface side of the substrate assembly for applying thepre-stressed pressure device to the skin of the patient, wherein thepressure member exerts end forces directed away from the patient and acentral force directed towards the patient.
 5. The pre-stressed pressuredevice for treating a wound or reduce reducing scarring of a skin of apatient as claimed in claim 4, wherein the pressure member exerts apressure ranging from 10-25 mm Hg to the wound of a patient when securedto the wound in the non-curved state.
 6. The pre-stressed pressuredevice of claim 4, wherein the substrate assembly comprises a wovencloth, a cotton, a natural and/or artificial fibers, a natural and/orgel materials, a natural or artificial foamed rubber and/or a vinylmaterial, or a combination thereof.
 7. The pre-stressed pressure deviceof claim 4, wherein the pressure member is pre-stressed and is curved inthe central portion and flat in the first and second end portions. 8.The pre-stressed pressure device of claim 4, wherein the pressure memberhas less curvature at the first and second end of the pressure memberthan at the center of the central portion of the pressure member.
 9. Thepre-stressed pressure device of claim 4, wherein the treatment devicecomprises a silicone pad, a gauze, an anti-bacterial agent treated pad,a coagulant agent treated pad, a hemostatic agent treated pad, a vitaminE treated pad, an antibiotic treated pad, an antiseptic treated pad, abotulism toxin treated pad, or a growth factors treated pad.
 10. Thepre-stressed pressure device of claim 4, wherein the pressure member hasa greater thickness in the first and second end portions than in thecentral portion.